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Identifiable Neuro Ethics Challenges to the Banking of Neuro Data

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Identifiable Neuro Ethics Challenges to the Banking of Neuro Data ILLES J, LOMBERA S. IDENTIFIABLE NEURO ETHICS CHALLENGES TO THE BANKING OF NEURO DATA. MINN. J.L. SCI. & TECH. 2009;10(1):71-94. Identifiable Neuro Ethics Challenges to the Banking of Neuro Data Judy Illes ∗ & Sofia Lombera** Laboratory and clinical investigations about the brain and behavioral sciences, broadly defined as “neuroscience,” have advanced the understanding of how people think, move, feel, plan and more, both in good health and when suffering from a neurologic or psychiatric disease. Shared databases built on information obtained from neuroscience discoveries hold true promise for advancing the knowledge of brain function by leveraging new possibilities for combining complex and diverse data.1 Accompanying these opportunities are ethics challenges that, in other domains like the sharing of genetic information, have an impact on all parties involved in the research enterprise. The ethics and policy challenges include regulating the content of, access to, and use of databases; ensuring that data remains confidential and that informed consent © 2009 Judy Illes and Sofia Lombera. ∗ Judy Illes, Ph.D., Corresponding author, National Core for Neuroethics, The University of British Columbia. The authors are grateful to Dr. Jack Van Horn, Dr. Peter Reiner, Patricia Lau, and Daniel Buchman for valuable discussions on the future of neuro data banks. Parts of this paper were presented at the conference “Emerging Problems in Neurogenomics: Ethical, Legal & Policy Issues at the Intersection of Genomics & Neuroscience,” February 29, 2008, University of Minnesota, Minneapolis, Minnesota by Judy Illes. Full video of that conference is available at http://www.lifesci.consortium.umn.edu/conference/neuro.php. Supported by CIHR/INMHA CNE-85117, CFI, BCKDF, and NIH/NIMH # 9R01MH84282- 04A1. All rights reserved. ** Sofia Lombera, B.Sc., is a Manager for Research & Global Partnerships, National Core for Neuroethics at the University of British Columbia. 1. See generally Shun-Ichi Amari et al., Neuroinformatics: The Integration of Shared Databases andTtools Towards Integrative Neuroscience, 1 J. INTEGRATIVE NEUROSCIENCE 117, 117–28 (2002); Jan G. Bjaalie & Sten Grillner, Global Neuroinformatics: The International Neuroinformatics Coordinating Facility, 27 J. NEUROSCIENCE, 3613, 3613–15 (2007); International Neuroinformatics Coordinating Facility, http://incf.org/ (last visited Dec. 11, 2008). 71 ILLES.WEB 2/20/2009 12:03:13 PM 72 MINN. J.L. SCI. & TECH. [Vol. 10:1 procedures account for future use and commercialization of data; and managing unexpected findings, data anonymization, and recontact procedures. Designing tools to address these challenges in parallel to the technical development of databases is pivotal to their success. While the centralization of neuroscience data in repositories has been met with considerable enthusiasm, this reaction is not uniform throughout the neuroscience community. Policy makers and developers should consider database organization, data sharing, and the obligations and expectations of investigators and accessors as neuroinformatics initiatives move forward. In this article, we identify specific ethics challenges presented by banked collections of “brain data” - genetic, molecular, structural, functional, and behavioral, obtained from human subjects, and we propose directions for research to foster the sharing of data in the future. NEUROINFORMATICS: A MODEL FOR DATA SHARING IN NEUROSCIENCE The motivation for the United States’ Human Brain Project (“HBP”) originated during the 1980s from discussions among neuroscientists and program directors at the National Institutes of Health (“NIH”) and the National Science Foundation (“NSF”) who supported the development of neuroinformatics tools that would enable sharing of data among neuroscience investigators.2 The tools involve a distributed set of “[w]eb-based databases, analytical tools, and knowledge management systems to foster sharing of data for all domains of neuroscience research.”3 Analytical tools developed in parallel to the databases now allow investigators to study the reliability of methods, to ensure that results are 2. Gordon M. Shepherd et al., The Human Brain Project: Neuroinformatics Tools for Integrating, Searching and Modeling Multidisciplinary Neuroscience Data, 21 TRENDS IN NEUROSCIENCE 460, 460 (1998); see also Michael F. Huerta & Stephen H. Koslow, Neuroinformatics: Opportunities Across Disciplinary and National Borders, 4 NEUROIMAGE S4, S4 (1996). 3. NIH GUIDE FOR GRANTS AND CONTRACTS, PROGRAM ANNOUNCEMENT, THE HUMAN BRAIN PROJECT (NEUROINFORMATICS): PHASE I - FEASIBILITY; PHASE II - REFINEMENTS, MAINTENANCE AND INTEGRATION (Dec. 3, 2002) available at http://grants.nih.gov/grants/guide/pa-files/PAR-03-035.html; see generally Stephen H. Koslow, Sharing Primary Data: A Threat or Asset to Discovery?, 3 NATURE REVIEWS NEUROSCIENCE 311 (2002). ILLES.WEB 2/20/2009 12:03:13 PM 2009] INDENTIFIABLE NEURO ETHICS CHALLENGES 73 reproducible, and carry out meta-analysis not supported by individual data sets. These data sets also allow researchers lacking access to equipment, such as brain scanners, to mine existing data.4 The HBP was ultimately created in response to a congressionally mandated initiative in the early 1990s and an Institute of Medicine review of progress in brain mapping.5 The momentum in this area was also international. At the Organization of Economic Cooperation and Development (“OECD”) Megascience Forum in 1999,6 the creation of a neurosciences database was a highlighted recommendation in the “effort to understand the structure, function, and development of the brain . [which] represents one of the great scientific challenges of the 21st century.”7 In 2002 Tom Insel, now head of the National Institutes of Mental Health (“NIMH”) of the NIH and colleagues wrote: “[W]e are entering a decade for which data-sharing will be the currency for progress in neuroscience.”8 Indeed, in recognition of this, the OECD created a Neuroinformatics Working Group and later the International Neuroinformatics Coordinating Facility (INCF) headquartered at Karolinska Instiutet in Stockholm, Sweden.9 The Human Brain Project:10 Phase I Feasibility Studies Report11 was the first to describe the practical implications of this effort to the scientific community and signaled the beginning of the initiative in the United States. Under the HBP grant program, first phase studies were focused on feasibility and proof of concept; later phase studies focused on refinements, including further testing of the tools across sites, 4. Governing Council of OHBM, Neuroimaging Databases, 292 SCIENCE 1673–76 (2001). 5. Shepard, supra note 2, at 461. 6. OECD MEGASCIENCE FORUM WORKING GROUP ON BIOLOGICAL INFORMATICS, FINAL REPORT OF THE OECD MEGASCIENCE FORUM WORKING GROUP ON BIOLOGICAL INFORMATICS 50 (1999), available at http://www.oecd.org/dataoedc/24/32/2105199.pdf. 7. Id. at 52. 8. Thomas R. Insel et al., Neuroscience Networks, 1 PLOS BIOLOGY 9, 10 (2003). 9. See Bjaalie & Grillner, supra note 1; International Neuroinformatics Coordinating Facility, http://incf.org/ (last visited Dec. 11, 2008). 10. Nat’l Inst. of Mental Health, Neuroinformatics: Human Brain Project, www.nimh.nih.gov/research-funding/scientific-meetings/recurring- meetings/human-brain-project/index.shtml (last visited Oct. 26, 2008). 11. NIH GUIDE FOR GRANTS AND CONTRACTS, PROGRAM ANNOUNCEMENT, THE HUMAN BRAIN PROJECT: PHASE I FEASIBILITY STUDIES (Oct. 6, 1995) available at http://grants.nih.gov/grants/guide/pa-files/PA-96-002.html. ILLES.WEB 2/20/2009 12:03:13 PM 74 MINN. J.L. SCI. & TECH. [Vol. 10:1 improvements, maintenance, and integration with other related web-based resources.12 As there is great diversity in the types of data generated by neuroscience research, novel approaches to collecting, manipulating, combining, displaying, retrieving, managing, and disseminating them have been vital to making these data available for scientific collaboration and electronic use. In response, neuroscience data repositories (e.g., the University of California—Los Angeles laboratory on mapping brain structure and function that houses among other data those from the Alzheimer’s Disease Neuroimaging Initiative,13 the Biomedical Informatics Research Network,14 and BrainNet Europe II15) have been developing at a steady pace. Some contain specialized data, for example, gene expression in the mouse brain16 (The Allen Brain Atlas17), single and multi-unit recordings (e.g., CoCoMac,18 Ear Lab,19 SenseLab20), and structural magnetic resonance imaging (“MRIs”) (e.g., Surface Management System Database, SumsDB21). Others, such as the functional MRI Data Center22 (“fMRIDC”) are repositories for imaging data obtained from functional magnetic resonance imaging (“fMRI”), in combination with other data collected from imaging modalities such as positron emission tomography (“PET”), 12. Id. at 5–6. 13. UCLA, Laboratory of Neuro Imaging, www.loni.ucla.edu (last visited Oct. 26, 2008). 14. Biomedical Informatics Research Network, www.nbirn.net (last visited Oct. 26, 2008). 15. BrainNet Europe, www.brainnet-europe.org (last visited Oct. 26, 2008); see also Jeanne E. Bell et al., Management of a Twenty-First Century Brain Bank: Experience in the BrainNet Europe Consortium, 115 ACTA NEUROPATHOL 497, 499 (2008). 16. Harry Hochhesier & Judith Yanowitz, If Only I Had a Brain: Exploring Mouse Brain Images in the Allen Brain Atlas, 99 BIOLOGY CELL 403 (2007). 17. Allen Inst. for Brain Sci., www.brain-map.org (last visited Oct. 26, 2008).
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